NCT05414409

The Gut Microbiome in Type 1 Diabetes and Mechanism of Metformin Action

The Gut Microbiome in Lean and Overweight Youth With Type 1 Diabetes and Novel Mechanism of Action of Metformin

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 114 (estimated)
• Sponsor: Heba M. Ismail · Academic / Other
• Sex: All
• Age: 11 Years – 18 Years
• Healthy volunteers: Not accepted

Summary

Ovwerweight and obesity prevalence in persons with T1D has increased, which further complicates management and risk for complications. The proposed study is relevant to public health because it helps us understand the role of the gut microbiome in disease pathophysiology in T1D youth with overweight and obesity as well as potential mechanisms to modify disease.

Conditions

• Type 1 Diabetes
• Obesity

Interventions

Type	Name	Description
DRUG	Metformin	Metformin is an oral medication that improves insulin sensitivity.

Timeline

• Start date: 2022-09-30
• Primary completion: 2026-11-02
• Completion: 2026-11-02
• First posted: 2022-06-10
• Last updated: 2025-07-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study